By: Cindy Carreto
The Department of Regulation and Control of Pharmaceutical and Related Products, Health Authorizations Unit, of the Ministry of Public Health and Social Assistance, has published on September 18, 2023, the new form F-AS-f-09 Version 19-2023. This update was made to modify the structure of the form
Some of the modifications made within the document are the following:
- Applicants must specify the changes to be made according to the procedure you wish to carry out, for example:
| Change modification in product name | FROM: enter current product name | A: Enter the name you want to change to |
| Change in the Monograph and Insert | CHANGES: specify the changes to be made in the document |
| Cancellation of Health Registration | DETAIL: enter reason for cancellation |
- Likewise, there is the option to indicate in the procedure box (when applicable), the specific modification to be carried out on the product to provide further details as required, forexample:
Change or addition of secondary packing
Change Addition
Change of company name of the manufacturer, packer or owner
Manufacturer Packer Owner
- The following procedures have been implemented in the form:
- Change of Strain(s)
- Change in the expression of excipients or active ingredient
- Cancellation of the Health Registry
- Temporary authorization for stock out of packaging or insert material.
- Additionally, the form also lists the modifications that must be notified to the Regulatory Authority and do not require prior approval, these include:
- Change of secondary packaging material or dimensions
- Change of primary and secondary packaging labeling design
- Discontinuation of registered presentations
- Change in product safety information
- Change or extension of distributor
- Change or addition of the manufacturer of the active ingredient
- Information directed to the patient through the prescribing doctor
- Others (any notification that is not established in the application form; The Regulatory Authority will evaluate whether the notification is appropriate or not)